The following data is part of a premarket notification filed by Cryodyne Technologies, Inc. with the FDA for Cryobiological Freezer.
| Device ID | K881465 |
| 510k Number | K881465 |
| Device Name: | CRYOBIOLOGICAL FREEZER |
| Classification | Apparatus, Cell-freezing And Reagents |
| Applicant | CRYODYNE TECHNOLOGIES, INC. 400 HOOVER RD. Soquel, CA 95073 |
| Contact | Dean W Schilling |
| Correspondent | Dean W Schilling CRYODYNE TECHNOLOGIES, INC. 400 HOOVER RD. Soquel, CA 95073 |
| Product Code | KSP |
| CFR Regulation Number | 864.9225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-06 |
| Decision Date | 1988-04-21 |